See country-specific product labeling for regulatory status. Others LumiraDx SARS-CoV-2 Ag Test Country Specific Labeling LumiraDx SARS-CoV-2 Ag PID00000897 10 418 168 001 10418168001 LumiraDx SARS-CoV-2 Ag Test (24T) JP LumiraDx SARS-CoV-2 Ag Test (24T) JP 05060537712055 Reagents, kits L016000107024 24 tests Not Available undefined The LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips (hereafter referred to as Test Strips) are to be used with the LumiraDx Platform. The LumiraDx Platform is a point of care system for professional use which is used for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test. This test is for HEALTHCARE PROFESSIONAL USE ONLY and allows users to perform tests using small sample volumes and to view results quickly on the Instrument touchscreen. en The LumiraDx SARS-CoV-2 Ag Test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform intended for the qualitative detection of the nucleocapsid protein antigen to SARSCoV-2 in nasal swab and nasopharyngeal swab samples. Samples are collected from individuals suspected of COVID-19 infection within the first twelve days of symptom onset or from asymptomatic individuals. The Test aids in the diagnosis of current SARS-CoV-2 infection by detection of SARSCoV-2 antigen. Positive results indicate the presence of viral antigens from infective virus, but clinical correlation with individual’s history and other diagnostic information is necessary to confirm infection status. Negative results do not rule out SARS-CoV-2 infection and should be considered in the context of an individual’s recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19. Results should not be used as the sole basis for treatment or case management decisions, including infection control decisions. The LumiraDx SARS-CoV-2 Ag Test is intended for use by individuals trained in point of care settings and proficient in performing tests using the LumiraDx Platform. en The LumiraDx SARS-CoV-2 Ag Test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform intended for the qualitative detection of the nucleocapsid protein antigens from SARSCoV- 2 in direct anterior nasal swab and nasopharyngeal swab specimens collected by a healthcare provider from individuals who are suspected of COVID-19 within the first twelve (12) days of symptom onset when tested at least twice over three days with at least 48 hours between tests and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests.Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.The LumiraDx SARS-CoV-2 Ag Test does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal swab and nasopharyngeal swab specimens during the acute phase of infection.Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definitive cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.All negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be considered in the context of a patient’s recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19.The LumiraDx SARS-CoV-2 Ag Test is intended for use by medical professionals or operators who are proficient in performing tests in point of care settings.The LumiraDx SARS-CoV-2 Ag Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved. en The LumiraDx SAR-CoV-2 Ag Test is a single use fluorescence immunoassay device designed to detect the presence of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab and nasopharyngeal swab samples. The test procedure involves collecting a nasal swab or nasopharyngeal swab sample using a recommended swab which is eluted into a vial containing Extraction Buffer. A single drop of the sample in Extraction Buffer is added to the Test Strip using the vial dropper cap provided. The LumiraDx Instrument is programmed to perform the test protocol using the dried reagents contained within the strip. The test result is determined from the amount of fluorescence the Instrument detects within the measurement zone of the Test Strip. The concentration of the analyte in the sample is proportional to the fluorescence detected. The results are displayed on the Instrument touchscreen within 12 minutes from the addition of the sample. en The LumiraDx SAR-CoV-2 Ag Test is a single use fluorescence immunoassay device designed to detect the presence of the nucleocapsid protein antigen directly from SARS-CoV-2 in either anterior nasal swab or nasopharyngeal swab samples, without transport media.The test procedure involves collecting an anterior nasal swab or nasopharyngeal swab sample using a recommended swab which is eluted into a vial containing Extraction Buffer. A single drop of the sample in Extraction Buffer is added to the Test Strip using the vial dropper cap provided. The LumiraDx Instrument is programmed to perform the test protocol using the dried reagents contained within the strip. The test result is determined from the amount of fluorescence the Instrument detects within the measurement zone of the Test Strip. The concentration of the analyte in the sample is proportional to the fluorescence detected. The results are displayed on the Instrument touchscreen within 12 minutes from the addition of the sample. en

体外診断用医薬品	製造販売承認番号：30300EZX00004000
測定原理	マイクロ流体免疫蛍光法
検体種	鼻咽頭ぬぐい液又は鼻腔ぬぐい液
測定時間	約12分
保存条件	2～30℃
使用条件	15～30 ℃
統一商品コード	518-636968
包装	24テスト

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